betamethasone + calcipotriol


LEO Pharma


Concise Prescribing Info
Per g Betamethasone dipropionate 0.5 mg, calcipotriol monohydrate 50 mcg
Topical treatment of psoriasis vulgaris in adults.
Dosage/Direction for Use
Flare treatment Apply to affected area once daily for 4 wk. Max daily dose: 15 g. (2-sec application delivers approx 0.5 g which covers skin area roughly corresponding to surface area of adult hand.) Long-term maintenance treatment Apply twice wkly on 2 non-consecutive days to previously affected areas w/ 2-3 days interval. Flare treatment should be re-initiated if signs of relapse occur.
Hypersensitivity. Erythrodermic & pustular psoriasis; Ca metabolism disorders; presence of viral (eg, herpes or varicella) skin lesions, fungal or bacterial skin & parasitic infections, skin TB manifestations; perioral dermatitis, atrophic skin, striae atrophicae, skin veins fragility, ichthyosis; acne vulgaris & rosacea; rosacea, ulcers, wounds in treatment area.
Special Precautions
Discontinue use if infection worsens or hypercalcaemia occurs. Adrenocortical suppression or impaired glycaemic control of DM; visual disturbances eg, cataract, glaucoma or central serous chorioretinopathy; risk of rebound effects upon discontinuation; guttate psoriasis. Avoid application under occlusive dressings, on large areas of damaged skin, mucous membranes or skin folds; contact w/ face, mouth & eyes. Not to be used in facial & genital skin. Long-term use. Avoid abrupt w/drawal. Avoid concurrent treatment w/ other steroids. May cause local skin reactions or irritation due to butylhydroxytoluene. Severe renal & hepatic impairment. Pregnancy. Not to be used during lactation. Childn <18 yr.
Adverse Reactions
Calcipotriol: Application site & hypersensitivity reactions, pruritus, skin irritation, burning & stinging sensation, dry skin, erythema, rash, dermatitis, aggravated psoriasis, photosensitivity. Betamethasone: Skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral & allergic contact dermatitis, depigmentation, colloid milia; generalised pustular psoriasis.
MIMS Class
Psoriasis, Seborrhea & Ichthyosis Preparations
ATC Classification
D05AX52 - calcipotriol, combinations ; Belongs to the class of other antipsoriatics for topical use.
Enstilar foam
60 g x 1's
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